mesalamine is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Mesalamine.
| Product ID | 68382-711_142e3b12-767f-4cfa-8bf0-123e1f201d44 |
| NDC | 68382-711 |
| Product Type | Human Prescription Drug |
| Proprietary Name | mesalamine |
| Generic Name | Mesalamine |
| Dosage Form | Tablet, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-06-19 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091640 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | MESALAMINE |
| Active Ingredient Strength | 1 g/1 |
| Pharm Classes | Aminosalicylate [EPC],Aminosalicylic Acids [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-06-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091640 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-06-19 |
| Marketing Category | ANDA |
| Application Number | ANDA091640 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-19 |
| Ingredient | Strength |
|---|---|
| MESALAMINE | 1.2 g/1 |
| SPL SET ID: | 533bfaf5-0add-4b49-a4f2-ddea2b83f65d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5907 | Mesalamine | Mesalamine |
| 0093-9224 | mesalamine | mesalamine |
| 0378-1375 | Mesalamine | mesalamine |
| 0378-7401 | Mesalamine | mesalamine Film Coated |
| 0378-9230 | Mesalamine | mesalamine |
| 68382-711 | mesalamine | mesalamine |
| 68382-484 | mesalamine | mesalamine |
| 68382-435 | mesalamine | mesalamine |
| 68382-649 | mesalamine | mesalamine |
| 0591-2245 | Mesalamine | Mesalamine |
| 70771-1110 | mesalamine | mesalamine |
| 70771-1071 | mesalamine | mesalamine |
| 16714-830 | mesalamine | mesalamine |
| 45802-923 | Mesalamine | Mesalamine |
| 45802-929 | Mesalamine | Mesalamine |
| 45802-098 | Mesalamine | Mesalamine |
| 50090-3497 | mesalamine | mesalamine |
| 54092-100 | Mesalamine | Mesalamine |
| 59762-0118 | Mesalamine | Mesalamine |
| 60687-408 | Mesalamine | Mesalamine |
| 60687-397 | Mesalamine | Mesalamine |
| 60687-347 | mesalamine | mesalamine |
| 62559-420 | Mesalamine | Mesalamine |
| 63304-175 | Mesalamine | Mesalamine |
| 59762-0117 | MESALAMINE | MESALAMINE |
| 64980-282 | Mesalamine | Mesalamine |
| 0781-7088 | Mesalamine | Mesalamine |
| 42291-564 | Mesalamine | Mesalamine |
| 42291-563 | Mesalamine | Mesalamine |
| 68682-113 | mesalamine | mesalamine |
| 0023-5901 | Asacol HD | mesalamine |
| 0023-5853 | Delzicol | mesalamine |
| 0179-0142 | Lialda | mesalamine |
| 0037-0066 | Rowasa | mesalamine |
| 0037-0022 | sfRowasa | mesalamine |